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Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The application of functional electrical stimulation (FES) has been used due to the high regenerative capacity of smooth muscle cells. This approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration.
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile dysfunction. The men included will be randomized into two groups. The intervention group will conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use FES placebo. Two sessions will be held weekly for four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES-sham | Sham Comparator | Functional Electro Stimulation (FES-sham) |
|
| Intervention (FES) | Active Comparator | functional electro stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electrical Stimulation (FES) | Device | FES (50Hz / 500us) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile function with International Index of Erectile Function-5 questionnaire | 2 times a week for 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2016 | |
| Reset | Jul 22, 2016 | |
| Release | Oct 7, 2018 | |
| Reset | Feb 15, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2016 | Jul 22, 2016 | |||
| Oct 7, 2018 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| FES- Sham |
| Device |
|
| Feb 15, 2019 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |